Comparison of dalteparin and apixaban in thromboprophylaxis

Phase 2

• Conditions: Thrombosis in bone marrow transplant patients.; Other complications of bone marrow transplant; T86.09

• Registration Number: IRCT20100127003210N25
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 11 January 2022

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Patients aged = 18 years, candidates for bone marrow stem cell transplantation
Weight = 40 kg
Khorona score = 2 or caprini score = 5
Life expectancy longer than 60 days and performance status score = 2 according to ECOG criteria
Creatinine clearance = 30 mL / min
Platelet count = 50000 / µL
Liver function test (AST, ALT) below three times the upper limit normal
INR = 1.6
No pregnancy

Exclusion Criteria

Bacterial endocarditis
Active bleeding, uncontrolled hypertension (SBP> 170, DBP> 110)
Patients receiving haploidentical allogenic transplantation consuming cyclophosphamide
Active bleeding in seven days or more before randomization
Severe liver disease (known as Childs Pugh cirrhosis class B or C) or kidney disease (creatinine clearance less than 30 ml / min)
Known anticoagulation disorder
Thrombocytopenia due to previous heparin use

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Thrombosis. Timepoint: One month (during hospitalization). Method of measurement: Color doppler sonography.

Secondary Outcome Measures

Name	Time	Method
Bleeding. Timepoint: One month (during hospitalization). Method of measurement: Evaluation of patient laboratory factors; Monitoring the patient for signs of bleeding.